NCT00354172 · ADVERSE EVENTS

Adverse events

Donor Umbilical Cord Blood Natural Killer Cells, Aldesleukin and Umbilical Cord Blood Transplant in Patients With Refractory Hematologic Cancers. · Source last updated 2017-12-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Serious adverse events were collected if deemed related to treatment from Day 1 through 1 year post transplant. It was expected that most treatment related adverse events would occur during this period.
Other-event reporting threshold: 5%

Only serious adverse events were captured for this study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Patients Treated for Refractory Hematologic Cancers All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.	16 / 16	0 / 0	Not reported / Not reported

Group identifiers: EG000: Patients Treated for Refractory Hematologic Cancers

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Death was due to transplant procedure.
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
16
num Events
4
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
16
num Events
5
term
Disease relapse
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
2
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
term
Hemorrhage, lung
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
2
term
Hepatic portal vein flow occluded
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
3
term
Pneumonia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

description

Only serious adverse events were captured for this study.

event Groups

description
All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
id
EG000
other Num Affected
0
other Num At Risk
0
serious Num Affected
16
serious Num At Risk
16
title
Patients Treated for Refractory Hematologic Cancers

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Death was due to transplant procedure.
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
16
num Events
4
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
16
num Events
5
term
Disease relapse
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
2
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
16
num Events
2
term
Hemorrhage, lung
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
16
num Events
2
term
Hepatic portal vein flow occluded
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
16
num Events
3
term
Pneumonia

time Frame

Serious adverse events were collected if deemed related to treatment from Day 1 through 1 year post transplant. It was expected that most treatment related adverse events would occur during this period.

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Preserved source evidence · Not medical advice